Aevumed, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Aevumed, Inc.” (first 2018, latest 2026), across 1 product code in 1 review panel. Median 510(k) review time under this name: 90 days. Since 2017 the median was 90 days, against 74 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 1 | 99 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 116 |
| 2023 | 1 | 80 |
| 2024 | 0 | — |
| 2025 | 2 | 173 |
| 2026 | 3 | 63 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Aevumed, Inc. took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 74 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 8 | 8 |
Review panels
- Orthopedic (8)
Most recent Aevumed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253065 | Aevumed SUPERCYNCH Button System | MBI | 2026-09-02 | 345 |
| K254306 | Aevumed FENIX Suture Anchor | MBI | 2026-03-04 | 63 |
| K260004 | Aevumed PROTEKT Suture Anchor | MBI | 2026-01-28 | 26 |
| K253040 | Aevumed FASE Suture Anchor | MBI | 2025-10-21 | 29 |
| K242895 | Aevumed PHANTOM Suture Anchors | MBI | 2025-08-06 | 317 |
| K223878 | Aevumed RAPID Suture Anchors | MBI | 2023-03-17 | 80 |
| K222363 | Aevumed PHANTOM-LP Suture Anchors | MBI | 2022-11-28 | 116 |
| K180464 | AEVUMED PHANTOM Suture Anchors | MBI | 2018-05-31 | 99 |
Recalls
openFDA lists no recalls under a recalling firm named Aevumed, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Aevumed, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Aevumed, Inc.” (first 2018, latest 2026), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Aevumed, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Aevumed, Inc. is 90 days. Since 2017: 90 days, versus 74 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Aevumed, Inc.?
The most frequent FDA product codes under this applicant name are MBI (Fastener, Fixation, Nondegradable, Soft Tissue, 8).
Next steps
- See all 8 Aevumed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MBI, Aevumed, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.